Reducing the incidence of HIV infection continues to be a crucial public health priority in the United States, especially among populations at elevated risk such as men who have sex with men, transgender women, people who inject drugs, and racial and ethnic minority communities. Although most HIV prevention efforts to date have focused on changing risky behaviors, the past decade yielded efficacious new biomedical technologies designed to prevent infection, such as the prophylactic use of antiretroviral drugs and the first indications of an efficacious vaccine. Access to prevention technologies will be a significant part of the next decade's response to HIV, and advocates are mobilizing to achieve more widespread use of these interventions. These breakthroughs, however, arrive at a time of escalating healthcare costs; health insurance coverage therefore raises pressing new questions about priority-setting and the allocation of responsibility for public health. The goals of this Article are to identify legal challenges and potential solutions for expanding access to biomedical HIV prevention through health insurance coverage. This Article discusses the public policy implications of HIV prevention coverage decisions, assesses possible legal grounds on which insurers may initially deny coverage for these technologies, and evaluates the extent to which these denials may survive external and judicial review. Because several of these legal grounds may be persuasive, particularly denials on the basis of medical necessity, this Article also explores alternative strategies for financing biomedical HIV prevention efforts.

I. INTRODUCTION

Since the 1980s, the human immunodeficiency virus (HIV) has shaped both legal systems and population curves around the world, profoundly transforming law and public health. Much of the advocacy about H/V has focused on access to treatment, but recent scientific breakthroughs are prompting a new focus on access to prevention technologies. Although HIV prevention research has long focused on behavioral means of reducing infection (e.g., encouraging individuals to use condoms or sterile drug injection equipment), the past decade has brought about a shift toward biomedical strategies for prevention. (1) This work is yielding promising, partially efficacious new methods for reducing the risk of infection, including the preventive use of antiretroviral (ARV) drugs as pre-exposure prophylaxis (PREP) and post-exposure prophylaxis (PEP), microbicide gels, vaccines, and adult male circumcision. (2) Recent studies have also identified preventive effects of established technologies, such as ARV treatment for HIV-infected individuals, the treatment of other sexually transmitted infections (STIs), the treatment of substance use disorders, and HIV testing and counseling. (3) Although individuals at elevated risk for HIV are often willing to use these interventions, many are unable or unwilling to pay the full cost of this medical care. (4) But as mathematical models reflect, the public health impact of biomedical HIV prevention strategies will depend in part on their widespread adoption by individuals at risk. (5) For this reason, the financing of biomedical prevention is likely to be a key question in the next phase of the U.S. response to HIV, and the costs of this care will interact with systemic priorities such as controlling healthcare costs and reducing the proportion of uninsured individuals. As biomedical HIV prevention technologies gain publicity and a firmer evidentiary base, public and private health insurers will encounter requests to cover these interventions, including legal challenges if coverage is denied. But coverage may not be an easy question. Some new prevention interventions may be brief and relatively inexpensive, such as a one-time vaccine, (6) a course of ARV drugs after near-certain exposure, (7) or male circumcision in communities of high risk. (8) Other interventions will entail higher costs and long-term monitoring by clinicians; cost-effectiveness remains unclear for these newer technologies. The initial and continuing costs of this preventive care could be high, and the financial benefits of averting infection may only be realized on a long-term basis because of the latency of HIV infection. Public and private insurers may also find it financially or politically problematic to provide coverage for medical interventions that mitigate the consequences of behavioral risk-taking, particularly when these risks include socially stigmatized behaviors such as unprotected sex or injection drug use. (9)

This context raises new questions for public health and the law, and this Article addresses one such question: Under existing law governing private and public health insurers in the United States, what legal challenges may influence the coverage of biomedical strategies for preventing HIV infection? This question specifically addresses whether existing insurers will extend coverage to specific health technologies for the purpose of reducing their policyholders' risk of acquiring HIV. (10) Health insurance coverage for preventive care is problematic for the U.S. healthcare system. Substantive coverage decisions by public and private insurers generally turn on whether care is "medically necessary," and prevailing interpretations have limited this term to treatment and diagnostic care. (11) Coverage for preventive healthcare may instead depend on whether such care is cost-effective for the insurer. Although these interpretive principles support the economic functions of insurance, they can undermine the uptake of preventive care. Individuals may be less willing to pay for preventive care than for treatment, (12) and given the higher burden of infectious and chronic disease among individuals of lower socioeconomic status, the out-of-pocket costs for preventive care may be least affordable for the individuals who are most at risk.

When we focus on technologies for the prevention of HIV, which is an infectious condition, these access problems are magnified. HIV affects the most socially and economically marginalized populations in the United States, and preventive technologies would have the greatest impact among the groups least able to pay for this care out-of-pocket. (13) Because HIV is infectious, efforts to reduce HIV prevalence in the most at-risk groups will in fact benefit the population as a whole. This is due to the phenomenon of "herd effects," in which all members of a community benefit from overall reductions in HIV prevalence. (14) Individuals who receive preventive care will reduce their risk of acquiring HIV, which reduces their risk of transmitting HIV to future partners, which then reduces the risk that those partners will transmit HIV to others, and so forth, culminating in a reduced population-level prevalence of infection. (15) Through the mechanism of herd effects, HIV prevention technologies may be cost-effective for a population as a whole-even if they are not cost-effective for individual insurers, who each may only cover a segment of the population at risk. The promise of herd effects distinguishes HIV prevention from the prevention of noncommunicable diseases (such as diabetes or heart disease). In this context, the cost-effectiveness calculations that insurers may use for coverage decisions may neglect the positive externalities that would make HIV prevention technologies potent. Given the socioeconomic features of the HIV epidemic, as well as the population-level promise of HIV prevention technologies, insurers' coverage decisions regarding biomedical HIV prevention are of paramount importance.

Where insurers' cost-effectiveness calculations do not support coverage, they may use a variety of legal grounds to avoid financing this care, including medical necessity, experimental treatment exceptions, off-label prescription exclusions, preexisting condition exclusions, and public policy arguments implicating moral hazard and adverse selection. (16) Where the sole purpose of an intervention is to reduce the risk of HIV acquisition, and particularly where the intervention is costly, several of these objections may be persuasive. Public health advocates should prepare to meet these objections, and alternative sources of financing could be needed to enable at-risk individuals to adopt biomedical HIV prevention strategies.

The ensuing Parts of this Article will identify legal mechanisms that public and private health insurers may use to challenge coverage for the emerging generation of biomedical HIV prevention interventions. One implication of this inquiry is the extent to which insurers should shoulder the costs of intervention in public health when illnesses are in part brought on by individual health behaviors. This question resonates with recent changes in U.S. healthcare financing, such as the requirement in the Patient Protection and Affordable Care Act (ACA) (17) prohibiting insurer discrimination on the basis of prior health status, even if conditions may stem in part from health behaviors. …

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